DQX · Class II · 21 CFR 870.1330

FDA Product Code DQX: Wire, Guide, Catheter

FDA product code DQX covers catheter guidewires used in intravascular procedures.

These thin, flexible wires are inserted into blood vessels to guide catheters, sheaths, and other devices to their target location. They are available in a wide range of diameters, stiffness profiles, and tip shapes optimized for different anatomical access points and clinical applications.

DQX devices are Class II medical devices, regulated under 21 CFR 870.1330 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Cordis Corp., Boston Scientific Corp and Asahi Intecc Co., Ltd..

764
Total
764
Cleared
116d
Avg days
1976
Since
764 devices
25–48 of 764
Cleared Jun 21, 2024
MINAMO blue
K240387
Asahi Intecc Co., Ltd.
Cardiovascular · 134d
Cleared Jun 13, 2024
FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
K240460
FMD Co., Ltd.
Cardiovascular · 118d
Cleared May 24, 2024
PacePro Wire
K240864
Opsens, Inc.
Cardiovascular · 57d
Cleared May 14, 2024
BNLE Hydrophilic Jacketed Peripheral Guidewire
K232662
Biomerics Nle
Cardiovascular · 257d
Cleared Oct 28, 2023
Mighty Wire Guide Wire
K230418
Merit Medical Systems, Inc.
Cardiovascular · 254d
Cleared Oct 24, 2023
Steerant™ Super Stiff Guidewire
K232570
Medtronic Vascular
Cardiovascular · 61d
Cleared Oct 11, 2023
VASSALLO GT Crossing14
K232574
Filmec Co. , Ltd.
Cardiovascular · 47d
Cleared Oct 11, 2023
VASSALLO GT 018 G12
K232578
Filmec Co. , Ltd.
Cardiovascular · 47d
Cleared Jul 20, 2023
CROSSLEAD Penetration Peripheral Guide Wire
K230377
Asahi Intecc Co., Ltd.
Cardiovascular · 157d
Cleared Jul 14, 2023
TalWire
K223791
Embrace Medical , Ltd.
Cardiovascular · 207d
Cleared May 05, 2023
Wattson temporary pacing guidewire (2250)
K230637
Vascular Solutions, LLC
Cardiovascular · 59d
Cleared Apr 28, 2023
BNLE Access Guidewire
K221390
Biomerics Nle
Cardiovascular · 350d
Cleared Mar 09, 2023
Vassallo GT 018 Hybrid
K223432
Filmecc Co., Ltd.
Cardiovascular · 115d
Cleared Mar 01, 2023
ProTrack Pigtail Wire
K213898
Baylis Medical Company, Inc.
Cardiovascular · 442d
Cleared Dec 19, 2022
Mechanical Guidewire
K221351
Baylis Medical Company, Inc.
Cardiovascular · 223d
Cleared Oct 26, 2022
VASSALLO GT EXT
K222631
Filmecc Co., Ltd.
Cardiovascular · 56d
Cleared Oct 07, 2022
Pre-Formed Blue
K221575
Lake Region Medical
Cardiovascular · 128d
Cleared Sep 21, 2022
EpiFaith CV
K212615
Flat Medical Co., Ltd.
Cardiovascular · 399d
Cleared Sep 14, 2022
SavvyWire
K213854
Opsens, Inc.
Cardiovascular · 278d
Cleared Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
K213868
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Aug 19, 2022
Stent Positioning Assistance System (SPAS)
K221917
Seven Sons , Ltd.
Cardiovascular · 50d
Cleared Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
K213315
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Jun 30, 2022
VASSALLO GT 018 Floppy
K213949
Filmecc Co., Ltd.
Cardiovascular · 195d
Cleared May 27, 2022
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
K212268
FMD Co., Ltd.
Cardiovascular · 311d